A Pre-post Intervention Study Evaluating Home-based Management of Patients With COPD or CAP

Not Applicable

Withdrawn

• Conditions: Chronic Obstructive Pulmonary Disease; Community-acquired Pneumonia
• Interventions: Device: Current Health platform

• Registration Number: NCT05009485
• Lead Sponsor: Current Health

Brief Summary

Risk of rehospitalization within 30 days of discharge is higher than 20% in patients with chronic obstructive pulmonary disease (COPD) and up to 20% for patients with community acquired pneumonia (CAP). This pre-post intervention study aims to quantify the impact of continuous remote patient monitoring (RPM) on rates of hospital readmission for patients presenting with CAP or exacerbation of COPD and compare the intervention group to historical controls that did not have access to the intervention. We hypothesize that an intervention combining remote patient monitoring with the remote clinical services and escalation pathways available at SSH (including the Mobile Integrated Health (MIH) program) will reduce hospital readmission within the 30 days following hospital discharge compared to standard of care in this population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-16
• Study First Posted: 2021-08-17
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-17
• Study Start: 2022-01-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 21 years or older
• confirmed diagnosis of moderate-severe COPD or community acquired pneumonia
• attendance at South Shore Hospital with an exacerbation of COPD / CAP
• fit for discharge to home

Exclusion Criteria

• suspicion of COVID-19 or confirmed COVID-19 positive
• life-threatening exacerbation requiring invasive ventilation or prolonged stay in critical care (> 24 hours)
• unable/unwilling to use Current Health
• bilateral axillary lymph node dissection
• persistent atrial fibrillation
• heavy tattooing on upper arms
• discharged to skilled nursing facility
• no access to home or mobile telephone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Current Health platform	Participants will be remotely monitored with the Current Health platform, respond to daily respiratory surveys, receive daily medication reminders and an action plan. Daily dashboard rounds and vital sign alarms from the continuously collected vital signs will be used to identify changes in health and escalated accordingly.

Primary Outcome Measures

Name	Time	Method
Number of participants with a hospital readmission	up to 30 days

Secondary Outcome Measures

Name	Time	Method
Rate of medication adherence	up to 30 days
Progression of Disease	up to 30 days	medication requirements, oxygen dependence, spirometric changes
Rate of clinical visits	up to 30 days	telehealth and/or ambulatory visits
Length of Stay	up to 30 days	original and subsequent readmissions or emergency department attendance
Rate of Mortality	up to 30 days
Time to service use	up to 30 days